13 дней назад
Senior Recall Specialist (Medical Devices)
85 200 - 133 300$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Recall Specialist (Medical Devices): Managing global field actions and recall strategies for Breast and Skeletal Health medical devices with an accent on regulatory compliance, health risk evaluations, and customer communications. Focus on developing recall assessments, coordinating regulatory interactions, tracking corrective actions, and maintaining complete field action documentation.
Location: Onsite in Newark, DE, United States; Marlborough, MA, United States
Annual base salary: $85,200–$133,300, plus bonus eligibility.
Company
develops medical technologies, including solutions for Breast and Skeletal Health.
What you will do
- Coordinate the preparation and execution of global field actions for the Breast and Skeletal Health divisions.
- Develop global recall strategies and regulatory communications with divisional stakeholders and international QA/RA representatives.
- Prepare Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments.
- Develop customer communications and field personnel FAQs with Marketing, Legal, R&D, Quality, and Regulatory teams.
- Support communications with regulatory bodies, Notified Bodies, and competent authorities.
- Track field action effectiveness, returned product reconciliation, quarantine and destruction, and supporting documentation.
Requirements
- BA/BS degree preferred.
- 5+ years of experience in quality assurance, regulatory affairs, or supply chain management in a heavily regulated industry.
- Experience with FDA regulations, recall guidance, and guidance distinguishing medical device recalls from enhancements.
- Familiarity with MEDDEV 2.12/1 guidance on medical device vigilance systems.
- Ability to assess product and project documentation, advocate for compliance, make independent decisions, resolve conflicts, and lead critical tasks.
- Onsite presence in the United States is required.
Culture & Benefits
- Comprehensive training is provided upon joining.
- Continued professional development and training are available throughout the career.
- Annual base salary is bonus eligible.
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